Trial Outcomes & Findings for Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers (NCT NCT00764361)

NCT ID: NCT00764361

Last Updated: 2017-04-07

Results Overview

Participants were monitored for 20 weeks during the study.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: every 2 weeks
• Results posted on: 2017-04-07

Participant Flow

subjects were recruited through the local veterans administration clinics

adult subjects with diabetic lower extremity ulcers were enrolled into the study after determination that the wound was not infected

Participant milestones

Measure	NanoDOX™ Hydrogel 1.0% doxycycline gel	Placebo placebo gel
Overall Study STARTED	8	7
Overall Study COMPLETED	6	3
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Measure	NanoDOX™ Hydrogel 1.0% doxycycline gel	Placebo placebo gel
Overall Study Withdrawal by Subject	2	3
Overall Study Adverse Event	0	1

Baseline Characteristics

Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers

Baseline characteristics by cohort

Measure	NanoDOX™ Hydrogel n=8 Participants 1.0% doxycycline gel	Placebo n=7 Participants placebo gel	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	64.99 years STANDARD_DEVIATION 11.53 • n=5 Participants	68.86 years STANDARD_DEVIATION 9.75 • n=7 Participants	66.33 years STANDARD_DEVIATION 10.53 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: every 2 weeks

Participants were monitored for 20 weeks during the study.

Outcome measures

Measure	NanoDOX™ Hydrogel n=8 Participants 1.0% doxycycline monohydrate gel	Placebo n=7 Participants placebo gel
Number of Participants Without Adverse Events	8 participants	7 participants

SECONDARY outcome

Timeframe: baseline, week 4, week 10, week 20

Outcome measures

Outcome data not reported

Adverse Events

NanoDOX™ Hydrogel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Abernethy, MD - Medical Director

Nanotherapeutics, Inc.

Phone: 386-462-9663

Email: jabernethy@nanotherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60